The Sunshine Act: Putting It into Practice – Interview with Karen Lovitch, Member, Mintz Levin
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more
On November 15, 2019, the Centers for Medicare and Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule....more
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. The Open Payments reporting requirements,...more
As reported in our 2015 Laboratory Industry Year in Review post, the laboratory industry began 2016 amid confusion regarding how to comply with the Protecting Access to Medicare Act of 2014 (PAMA), which made the most...more
In a final rule published in the Federal Register on November 13, 2014, the Centers for Medicare and Medicaid Services (CMS) eliminated the federal Sunshine Act reporting exclusion for payments to physicians at continuing...more
The Centers for Medicare & Medicaid Services (CMS) published a final rule with comment period addressing, among other issues, changes to the reporting and data collection requirements imposed upon “applicable manufacturers”...more
On October 31, 2014, the Centers for Medicare & Medicaid Services (CMS) issued its final Medicare physician fee schedule rule for CY 2015 (the Final Rule), which also includes certain changes to the Sunshine Regulations. ...more
The Centers for Medicare & Medicaid Services (“CMS”) has finalized changes to a number of reporting requirements under the regulations implementing the Physician Payments Sunshine Act (“Final Rule”). When CMS proposed...more
Congress begins its summer recess this week, but last week legislators were busy holding hearings on management issues regarding HealthCare.gov, introducing legislation to increase payments to primary care doctors under...more
On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) released four proposed changes for comment to the implementing regulations for the Physician Payments Sunshine Act. The proposed changes would amend the...more
In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more
In this issue: - Best Patent Practices Under the America Invents Act - CMS Issues Final Rule for Implementing Sunshine Act - New IP Litigation Team a Boon for Firm's Life Sciences and Technology Clients ...more
The final regulations implementing the Physician Payments Sunshine Act take effect April 9, 2013. Pharmaceutical manufacturers, group purchasing organizations, academic medical centers and physicians need to be ready to...more
“Applicable Manufacturers” - Common Ownership Considered to be Ownership by the Same Individuals or Entities of 5 Percent or More in Two Entities - In the Final Rule, CMS defines “applicable manufacturer” as an...more
Report Submission and Review Pre-Submission Review is Not Required Applicable manufacturers may voluntarily provide covered recipients the opportunity to review the data prior to submission to CMS, but doing so is not...more
“Payments or Other Transfers of Value” Payments or Other Transfer of Value Must Have a Discernible Economic Value.In the Final Rule, CMS interprets value as the discernible economic value on the open market in the United...more